Device Classification Name |
system, facet screw spinal device
|
510(k) Number |
K994308 |
Device Name |
NUVASIVE TOWNLEY FACET SCREW |
Applicant |
NUVASIVE, INC. |
10065 OLD GROVE RD. |
SAN DIEGO,
CA
92131
|
|
Applicant Contact |
STEVE REITZLER |
Correspondent |
NUVASIVE, INC. |
10065 OLD GROVE RD. |
SAN DIEGO,
CA
92131
|
|
Correspondent Contact |
STEVE REITZLER |
Classification Product Code |
|
Date Received | 12/21/1999 |
Decision Date | 04/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|